Can a smaller biopharma have any leverage with bigger, multinational CDMOs? Biotech Genisphere is giving it a try. So far, so good. Here’s why.
Part of the Cleaning Validation for the 21st Century series
The convergence of regulatory agencies and acceptance of ICH Q12 across multiple agencies opens up opportunities for changes with minimal supply chain disruptions. The guidance facilitates management of post-approval CMC changes in a predictable and efficient manner.
Virtually every biotech or pharmaceutical company relies on contract development and manufacturing organizations (CDMOs) for R&D and manufacturing services or to access specialized technology to bring their drug candidates to the market. Identifying and selecting CDMOs is a lengthy and difficult process, and it is critically important to select the right partner.
Several characteristics are important to the performance of BPCs, including biological compatibility, physical and mechanical properties, and extractables and leachables (E&L).
The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using single-use technology.
Developed by the FDA, the Biopharmaceutics Classification System helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.
Follow the paths of two companies as they learn how a science-led, risk-based development approach yields a more successful outcome in the long run.
The demand for generic drugs is skyrocketing. According to the US FDA, nearly 8 in 10 prescriptions filled in the United States are for generic drugs. Generic drugs can be considerably less expensive while typically providing the same level of effectiveness as brand name therapeutics. The demand is intensified by initiatives such as the Affordable Care Act that intend to lower the cost of national healthcare by compelling a move toward less expensive generics and biosimilars.
The medical device industry faces the challenge of delivering safe and cost-effective products on time, every time. By Ken Peterson
The end of 2013 saw numerous drugs change clinical phase or receive approval and launch, creating an exciting landscape for drugs to watch in 2014. Whether it’s a new HIV drug gaining approval or the advancement of a rheumatoid arthritis therapy from phase II to phase III trials, The Ones to Watch, a quarterly report from Thomson Reuters, keeps a finger on the pulse of the most promising drugs by mining strategic data from CortellisTM Competitive Intelligence.
Using these insights, Thomson Reuters analysts found that orphan drugs feature prominently in the market, with the recent launch of two drugs for orphan cancer indications: GazyvaTM and ValchlorTM, and important phase transitions for several others. In the US there have been nearly 250 labeled indications relating to orphan drug designations approved since the enactment of the Orphan Drug Act in 1983. Cortellis Competitive Intelligence describes over 800 drugs that have received at least one orphan designation.
In the world of pharmaceutical supply chains, where cost reduction is king and a growing number of products are temperature controlled – collecting, communicating and analyzing temperature and logistics data is critical to success.
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The development of a robust and consistent bioprocess requires a systematic and risk-based approach to identify the right process parameters and raw materials.
Microbiological contamination is at the top of the CDMO threat list. A CDMO needs to have clearly defined procedures and allow client access to data.
Having a solid understanding of the most common API challenges can help to avoid development delays, rework or outright failure.
By recognizing the limitations of today’s production processes, the industry may be able to overcome the challenges, complexity, and high cost of manufacturing vaccines and viral vector-based therapies.
With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec.